J Forensic Sci, September 2015, Vol. 60, No. 5 doi: 10.1111/1556-4029.12769 Available online at: onlinelibrary.wiley.com
PAPER PATHOLOGY/BIOLOGY
Lin-Sheng Yu,1,2 M.M.; Guang-Hua Ye,1,2 M.M.; Yan-Yan Fan,1,2 Ph.D.; Xing-Biao Li,1,2 B.M.; Xiang-Ping Feng,1,2 M.M.; Jun-Ge Han,1,2 Ph.D.; Ke-Zhi Lin,1,2 M.M.; Miao-Wu Deng,1,2 B.M.; and Feng Li,1,2,3 M.D., J.D., Ph.D.
Analysis of Forensic Autopsy in 120 Cases of Medical Disputes Among Different Levels of Institutional Settings
ABSTRACT: Despite advances in medical science, the causes of death can sometimes only be determined by pathologists after a complete
autopsy. Few studies have investigated the importance of forensic autopsy in medically disputed cases among different levels of institutional settings. Our study aimed to analyze forensic autopsy in 120 cases of medical disputes among five levels of institutional settings between 2001 and 2012 in Wenzhou, China. The results showed an overall concordance rate of 55%. Of the 39% of clinically missed diagnosis, cardiovascular pathology comprises 55.32%, while respiratory pathology accounts for the remaining 44. 68%. Factors that increase the likelihood of missed diagnoses were private clinics, community settings, and county hospitals. These results support that autopsy remains an important tool in establishing causes of death in medically disputed case, which may directly determine or exclude the fault of medical care and therefore in helping in resolving these cases.
KEYWORDS: forensic science, forensic autopsy, clinical settings, medical disputes, concordance, missed diagnosis, misdiagnosis
Medical disputes over patient deaths are an increasingly difficult problem in China today. A medical dispute generally refers to the disagreement between families of patients and healthcare providers over the outcomes of the medical treatment and the causes of outcomes during medical treatment. In such cases, families submit a dispute to health administrative agencies or judicial authorities for accountability or indemnification for loses. An accurate and well-accepted determination of cause of death is therefore essential in settling these disputes. Autopsy is traditionally the most direct and effective means of determining cause of death. There are fundamentally two types of autopsy: the clinical/hospital autopsy and the forensic/medicolegal autopsy. The clinical autopsy is generally ordered by either the hospital or family on hospital patients when cause of death is in question, effectiveness of diagnosis and treatment is in question, or for education, training, and quality assurance of the hospital staff (1). The forensic autopsy or medicolegal autopsy is performed when cases involve unnatural, unusual, or traumatic situations. Cases with medical disputes can be performed by either clinical autopsy or forensic autopsy.
1 Department of Forensic Medicine, Wenzhou Medical University, 82 Wenzhou West College Road, Wenzhou, Zhejiang Province, 325035, P. R. China. 2 Institute of Forensic Science, Wenzhou Medical University, 82 Wenzhou West College Road, Wenzhou, Zhejiang Province, 325035, P. R. China. 3 Forensic Medical Management Services, 850 R. S. Gass Blvd, Nashville, TN, 37216. Received 4 Mar. 2014; and in revised form 30 June 2014; accepted 14 July 2014.
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Many studies have shown that clinical autopsy rates in the USA and Europe have been in dramatic decline for the last half of the century, from approximately 60% in the 1960s to 10% by 2005 (2,3). Multiple reasons have been cited for the decrease in autopsy rates, including progress in clinical diagnosis of diseases, especially with the technological advances in clinical testing and imaging; public opposition to the postmortem dissection and examination of human bodies; fear of potential medicolegal problems that could result from autopsy which may reveal medical mistakes; and a declining interest in autopsies among hospital pathologists (3,4). Despite these factors, clinicopathologic discrepancy rates remain high and relatively constant over the last 50 years (5–7). In 2002, China’s State Council established the “Regulations of Medical Malpractice,” which mandates hospitals perform an autopsy within 48 h after death in cases of medical dispute or unknown cause of death. In the event, an autopsy is unavailable within 48 h, the body shall be cryopreserved to avoid the decomposition and autolysis of the body and tissue which may affect the accurate pathological diagnosis, and an autopsy must be performed within 7 days. Currently, the rate of autopsy use remains very low for medical disputes in China, which often adversely affects the outcomes of the disputed cases. This department and institute of forensic medicine handle the majority of cases of autopsy involving medical disputes in the District of Wenzhou, Zhejiang Province. Few studies have been published to demonstrate the importance of forensic autopsy in cases of medical dispute among different institutional settings. The purpose of the present study was to use forensic autopsy to evaluate the spectrum of clinically missed diagnoses in medically disputed cases among different levels of hospital settings. © 2015 American Academy of Forensic Sciences
YU ET AL.
Materials and Methods Medical records and autopsy reports including histopathologic examination were collected and retrospectively analyzed for the 120 autopsy cases involved in medical disputes from 2001 to 2012 in five different institutional settings: provincial level hospitals, city level hospitals, county level hospitals, community hospitals, and private clinics. All forensic autopsies were performed in the Department and Institute of Forensic Medicine, Wenzhou Medical University.
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120 FORENSIC AUTOPSIES AMONG DIFFERENT SETTINGS
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diseases (15 cases, 12.50%), central nervous system diseases (7 cases, 5.83%), reproductive system diseases (19 cases, 15.83%), and unknown diseases (47 cases, 39.17%). The Distribution of Forensic Diagnosis The causes of death of 120 cases were determined by forensic autopsy, including cardiovascular system diseases (48 cases, 40%), respiratory system diseases (38 cases, 31.67%), digestive system diseases (13 cases, 10.83%), central nervous system diseases (6 cases, 5%), and reproductive system diseases (15 cases, 12.50%).
Results The Incidence Rate of Autopsy and the Rate of Autopsy
The Concordance Rate of Clinical and Forensic Diagnosis
From 2001 to 2012, our department and institute accepted 568 cases of autopsy. Among these cases, 120 cases were involved in medical disputes. The incidence rate of autopsy was 21.13%. In the meantime, the health system of Wenzhou City accepted 525 death cases involving medical disputes. The autopsy rate was 22.86%.
In 120 cases, the overall rate of concordance of clinical and forensic diagnoses was 55% (66 cases). The clinical diagnoses of 7 cases (5.83%) were not consistent with the ones established by the forensic pathologist after performing the autopsy. The causes of death of 47 cases of unknown clinical diagnoses (39.17%) were revealed by forensic autopsy (Table 1). Among the different levels of institutional settings, the overall rate of concordance of clinical and forensic diagnoses was significantly higher in provincial level hospitals (90%) and city level hospitals (82.6%) than the county level hospitals (54.17%), community level hospitals (35%), and private clinics (26.32%) (Fig. 2).
Age Distribution Among the 120 cases autopsied, the age ranged from 0 to 86 years old, with the distributions as follows: neonates and infants (27 cases, 22.50%), 1–9 years (7 cases, 5.83%), 10–19 years (8 cases, 6.67%), 20–29 years (21 cases, 17.50%), 30–39 years (22 cases, 18.34%), 40–49 years (12 cases, 10%), 50–59 years (13 cases, 10.83%), and over 60 years old (10 cases, 8.33%) (Fig. 1). Sex Distribution In 120 cases, 65 were male (54.17%) and 55 were female (45.83%). Institutional Setting in Medical Disputes In this study, these 120 cases involved in the medical disputes came from five institutional settings. They included 10 cases from the provincial hospitals (8.33%), 23 cases from the city hospitals (19.17%), 48 cases from the county hospitals (40%), 20 cases from the community hospitals (16.67%), and 19 cases from private clinics (15.83%). The Distribution of Clinical Diagnosis One hundred and twenty cases had different clinical diagnosis, including cardiovascular system diseases (15 cases, 12.50%), respiratory system diseases (17 cases, 14.17%), digestive system
FIG. 1––Age distribution of 120 forensic autopsy cases.
Discussion The authors demonstrate in the present study an overall concordance of 55% between clinical diagnoses and the causes of death established by the forensic pathologists. These results are consistent with the results of other similar studies, including Pakis, who found a concordance rate of 49.1% in cases where clinicians were accused of malpractice (6,7). A missed diagnosis or undiagnosed case refers to the circumstance where no diagnosis is made clinically until postmortem examination. A misdiagnosis occurs when the autopsy results are not consistent with the clinical diagnosis. A disparity is defined as differences between the clinical diagnoses and postmortem findings including both missed diagnosis and misdiagnosis. Pathologies of the cardiovascular system account for 55.32% of undiagnosed cases. These findings are consistent with the literature. Seventeen percent of missed diagnoses were due to atherosclerotic coronary artery disease, which is comparable to TABLE 1––The main forensic pathology diagnosis of 47 unknown cases. Forensic Pathology Diagnosis Coronary atherosclerotic heart disease Myocarditis Rupture of aortic dissection Cardiomyopathy Valvular disease of heart Cardiac conduction system disease Anaphylactic shock Hemorrhagic shock Septic shock Bacterial pneumonia Interstitial pneumonia Pulmonary embolism Lung cancer Neonatal pulmonary hemorrhage Neonatal hyaline membrane disease Total
Number
Percentage (%)
8 3 3 3 2 1 3 2 1 5 6 4 2 3 1 47
17.02 6.38 6.38 6.38 4.26 2.13 6.38 4.26 2.13 10.64 12.76 8.51 4.26 6.38 2.13 100
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JOURNAL OF FORENSIC SCIENCES
FIG. 2––The diagnosis concordance rate in different medical institutions *p
PAPER PATHOLOGY/BIOLOGY
Lin-Sheng Yu,1,2 M.M.; Guang-Hua Ye,1,2 M.M.; Yan-Yan Fan,1,2 Ph.D.; Xing-Biao Li,1,2 B.M.; Xiang-Ping Feng,1,2 M.M.; Jun-Ge Han,1,2 Ph.D.; Ke-Zhi Lin,1,2 M.M.; Miao-Wu Deng,1,2 B.M.; and Feng Li,1,2,3 M.D., J.D., Ph.D.
Analysis of Forensic Autopsy in 120 Cases of Medical Disputes Among Different Levels of Institutional Settings
ABSTRACT: Despite advances in medical science, the causes of death can sometimes only be determined by pathologists after a complete
autopsy. Few studies have investigated the importance of forensic autopsy in medically disputed cases among different levels of institutional settings. Our study aimed to analyze forensic autopsy in 120 cases of medical disputes among five levels of institutional settings between 2001 and 2012 in Wenzhou, China. The results showed an overall concordance rate of 55%. Of the 39% of clinically missed diagnosis, cardiovascular pathology comprises 55.32%, while respiratory pathology accounts for the remaining 44. 68%. Factors that increase the likelihood of missed diagnoses were private clinics, community settings, and county hospitals. These results support that autopsy remains an important tool in establishing causes of death in medically disputed case, which may directly determine or exclude the fault of medical care and therefore in helping in resolving these cases.
KEYWORDS: forensic science, forensic autopsy, clinical settings, medical disputes, concordance, missed diagnosis, misdiagnosis
Medical disputes over patient deaths are an increasingly difficult problem in China today. A medical dispute generally refers to the disagreement between families of patients and healthcare providers over the outcomes of the medical treatment and the causes of outcomes during medical treatment. In such cases, families submit a dispute to health administrative agencies or judicial authorities for accountability or indemnification for loses. An accurate and well-accepted determination of cause of death is therefore essential in settling these disputes. Autopsy is traditionally the most direct and effective means of determining cause of death. There are fundamentally two types of autopsy: the clinical/hospital autopsy and the forensic/medicolegal autopsy. The clinical autopsy is generally ordered by either the hospital or family on hospital patients when cause of death is in question, effectiveness of diagnosis and treatment is in question, or for education, training, and quality assurance of the hospital staff (1). The forensic autopsy or medicolegal autopsy is performed when cases involve unnatural, unusual, or traumatic situations. Cases with medical disputes can be performed by either clinical autopsy or forensic autopsy.
1 Department of Forensic Medicine, Wenzhou Medical University, 82 Wenzhou West College Road, Wenzhou, Zhejiang Province, 325035, P. R. China. 2 Institute of Forensic Science, Wenzhou Medical University, 82 Wenzhou West College Road, Wenzhou, Zhejiang Province, 325035, P. R. China. 3 Forensic Medical Management Services, 850 R. S. Gass Blvd, Nashville, TN, 37216. Received 4 Mar. 2014; and in revised form 30 June 2014; accepted 14 July 2014.
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Many studies have shown that clinical autopsy rates in the USA and Europe have been in dramatic decline for the last half of the century, from approximately 60% in the 1960s to 10% by 2005 (2,3). Multiple reasons have been cited for the decrease in autopsy rates, including progress in clinical diagnosis of diseases, especially with the technological advances in clinical testing and imaging; public opposition to the postmortem dissection and examination of human bodies; fear of potential medicolegal problems that could result from autopsy which may reveal medical mistakes; and a declining interest in autopsies among hospital pathologists (3,4). Despite these factors, clinicopathologic discrepancy rates remain high and relatively constant over the last 50 years (5–7). In 2002, China’s State Council established the “Regulations of Medical Malpractice,” which mandates hospitals perform an autopsy within 48 h after death in cases of medical dispute or unknown cause of death. In the event, an autopsy is unavailable within 48 h, the body shall be cryopreserved to avoid the decomposition and autolysis of the body and tissue which may affect the accurate pathological diagnosis, and an autopsy must be performed within 7 days. Currently, the rate of autopsy use remains very low for medical disputes in China, which often adversely affects the outcomes of the disputed cases. This department and institute of forensic medicine handle the majority of cases of autopsy involving medical disputes in the District of Wenzhou, Zhejiang Province. Few studies have been published to demonstrate the importance of forensic autopsy in cases of medical dispute among different institutional settings. The purpose of the present study was to use forensic autopsy to evaluate the spectrum of clinically missed diagnoses in medically disputed cases among different levels of hospital settings. © 2015 American Academy of Forensic Sciences
YU ET AL.
Materials and Methods Medical records and autopsy reports including histopathologic examination were collected and retrospectively analyzed for the 120 autopsy cases involved in medical disputes from 2001 to 2012 in five different institutional settings: provincial level hospitals, city level hospitals, county level hospitals, community hospitals, and private clinics. All forensic autopsies were performed in the Department and Institute of Forensic Medicine, Wenzhou Medical University.
.
120 FORENSIC AUTOPSIES AMONG DIFFERENT SETTINGS
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diseases (15 cases, 12.50%), central nervous system diseases (7 cases, 5.83%), reproductive system diseases (19 cases, 15.83%), and unknown diseases (47 cases, 39.17%). The Distribution of Forensic Diagnosis The causes of death of 120 cases were determined by forensic autopsy, including cardiovascular system diseases (48 cases, 40%), respiratory system diseases (38 cases, 31.67%), digestive system diseases (13 cases, 10.83%), central nervous system diseases (6 cases, 5%), and reproductive system diseases (15 cases, 12.50%).
Results The Incidence Rate of Autopsy and the Rate of Autopsy
The Concordance Rate of Clinical and Forensic Diagnosis
From 2001 to 2012, our department and institute accepted 568 cases of autopsy. Among these cases, 120 cases were involved in medical disputes. The incidence rate of autopsy was 21.13%. In the meantime, the health system of Wenzhou City accepted 525 death cases involving medical disputes. The autopsy rate was 22.86%.
In 120 cases, the overall rate of concordance of clinical and forensic diagnoses was 55% (66 cases). The clinical diagnoses of 7 cases (5.83%) were not consistent with the ones established by the forensic pathologist after performing the autopsy. The causes of death of 47 cases of unknown clinical diagnoses (39.17%) were revealed by forensic autopsy (Table 1). Among the different levels of institutional settings, the overall rate of concordance of clinical and forensic diagnoses was significantly higher in provincial level hospitals (90%) and city level hospitals (82.6%) than the county level hospitals (54.17%), community level hospitals (35%), and private clinics (26.32%) (Fig. 2).
Age Distribution Among the 120 cases autopsied, the age ranged from 0 to 86 years old, with the distributions as follows: neonates and infants (27 cases, 22.50%), 1–9 years (7 cases, 5.83%), 10–19 years (8 cases, 6.67%), 20–29 years (21 cases, 17.50%), 30–39 years (22 cases, 18.34%), 40–49 years (12 cases, 10%), 50–59 years (13 cases, 10.83%), and over 60 years old (10 cases, 8.33%) (Fig. 1). Sex Distribution In 120 cases, 65 were male (54.17%) and 55 were female (45.83%). Institutional Setting in Medical Disputes In this study, these 120 cases involved in the medical disputes came from five institutional settings. They included 10 cases from the provincial hospitals (8.33%), 23 cases from the city hospitals (19.17%), 48 cases from the county hospitals (40%), 20 cases from the community hospitals (16.67%), and 19 cases from private clinics (15.83%). The Distribution of Clinical Diagnosis One hundred and twenty cases had different clinical diagnosis, including cardiovascular system diseases (15 cases, 12.50%), respiratory system diseases (17 cases, 14.17%), digestive system
FIG. 1––Age distribution of 120 forensic autopsy cases.
Discussion The authors demonstrate in the present study an overall concordance of 55% between clinical diagnoses and the causes of death established by the forensic pathologists. These results are consistent with the results of other similar studies, including Pakis, who found a concordance rate of 49.1% in cases where clinicians were accused of malpractice (6,7). A missed diagnosis or undiagnosed case refers to the circumstance where no diagnosis is made clinically until postmortem examination. A misdiagnosis occurs when the autopsy results are not consistent with the clinical diagnosis. A disparity is defined as differences between the clinical diagnoses and postmortem findings including both missed diagnosis and misdiagnosis. Pathologies of the cardiovascular system account for 55.32% of undiagnosed cases. These findings are consistent with the literature. Seventeen percent of missed diagnoses were due to atherosclerotic coronary artery disease, which is comparable to TABLE 1––The main forensic pathology diagnosis of 47 unknown cases. Forensic Pathology Diagnosis Coronary atherosclerotic heart disease Myocarditis Rupture of aortic dissection Cardiomyopathy Valvular disease of heart Cardiac conduction system disease Anaphylactic shock Hemorrhagic shock Septic shock Bacterial pneumonia Interstitial pneumonia Pulmonary embolism Lung cancer Neonatal pulmonary hemorrhage Neonatal hyaline membrane disease Total
Number
Percentage (%)
8 3 3 3 2 1 3 2 1 5 6 4 2 3 1 47
17.02 6.38 6.38 6.38 4.26 2.13 6.38 4.26 2.13 10.64 12.76 8.51 4.26 6.38 2.13 100
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FIG. 2––The diagnosis concordance rate in different medical institutions *p
